Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assessment of behavior of the child before and during and after the pulpotomy procedures.
研究概览
简要总结
The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children attended the dental clinic for their first time.
- •Children aged between 4 to 6 years including both boys and girls.
- •Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.
- •Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.
排除标准
- •1.Children with known significant visual impairments or psychological problems.
- •Children suffering from systemic diseases or special health care needs.
研究组 & 干预措施
Group 1 (Tell-Show-Do)
干预措施: Group 1 (Tell-Show-Do) (Other)
Group 2 ( Tell-Show-Play-Doh)
干预措施: The Play-Doh Doctor Drill 'n Fill toy set (Behavioral)
Group 3 (Kaleidoscope glasses )
干预措施: Using Kaleidoscope glasses during pulpotomy procedures (Behavioral)
结局指标
主要结局
Assessment of behavior of the child before and during and after the pulpotomy procedures.
时间窗: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.
* Assessment of behavior of the child using ( Frankl's behavior rating scale to measure the cooperation behavior of the child, FLACC scale ). * Frankl's behavior rating scale was used pre-operatively and post-operatively with 4 scores : score 1(Definitely negative) score 2(Negative) score 3(Positive) score 4 (Definitely positive), the best scores for positive attitude and cooperation are score 3, 4. * The FLACC scale was used to measure behavior of the child according to Face, Legs, Activity, Cry and Consolability during the pulpotomy procedures with Scores: (0 = Relaxed and comfortable) (1-3 = Mild discomfort ) (4-6 = Moderate pain) (7-10 = Severe discomfort/pain).
Assessment of anxiety of the child before and after the pulpotomy procedures.
时间窗: Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.
* Assessment of anxiety of the child using (Pulse Oximeter to measure heart rate pre-operatively and post-operatively, RMS Pictorial Scale at the end of the visit). Increasing in heart rate readings means increasing anxiety. * RMS Pictorial Scale which comprises a row of five faces ranging from score 1(very happy) to score 5 (very unhappy) and the children were asked to choose the face they felt like about themselves at that moment.
次要结局
未报告次要终点
研究者
Eman Mohamed Yousef Mohamed Elmansy
Master's degree student, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Mansoura University
Mansoura University